Do Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux Predict Response to Treatment?

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine if tissue changes are predictor of clinical response to therapy.

The hypothesis is that the patients who have laryngeal signs and symptoms related to acid reflux, will have ultrastructural changes on a laryngeal biopsy which are predictors of response to therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Treatments: Dexlansoprazole; Lansoprazole

Criteria

Inclusion Criteria:

GERD

• Documented erosive esophagitis:

• Patients will be newly diagnosed with esophageal erosion at initial visit via EGD

• Patients with non-erosive esophagitis who have been responsive to PPI

LPR

• Diagnosed via Head & Neck Institute endoscopists:

• pts with chronic (> 3-months) history of hoarseness, throat clearing, sore- or burning throat and globus

• Documentation of LPR using Larynx/Pharynx exam.

This group is commonly evaluated at the Vanderbilt Voice Center.

Exclusion Criteria:

• Age < 18yrs

• Pregnancy

• Patients with contra-indications for EGD

• Patients on corticosteroids

• Active smokers

• Patients with a history of regular (> 2 /day) alcohol use.

• Use of antacid (PPI, H2RB) within last 30 days

• Use of any/all medications affecting gastrointestinal motility

• Known history of: Barrett's esophagus, Peptic stricture, Pyloric stenosis, Gastric resection

• Patients unable to give informed consent

• Patients unable to comply with follow-up

• Patients with known contraindication to lansoprazole.

• Contraindications to biopsy: Taking anticoagulants other than aspirin (Coumadin, Plavix) or allergic to the local anesthetics.